USA – FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections

Today, the U.S. Food and Drug Administration permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic joint infection (infection around a joint replacement) in the synovial (lubricant) fluid of patients being evaluated for revision surgery, which is surgery performed to replace or compensate for a failed implant.

“Prior to today’s authorization, there were no FDA-authorized diagnostic tests specifically designed to help health care professionals determine whether the inflammation around a prosthetic joint was due to an infection or another cause,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “With this test, health care professionals now have an additional option available to aid their clinical assessment as to whether the patient has an infection and requires revision surgery. Whereas before surgeons may have opted for surgery when the presence of an infection was unclear, with this test, they have more information and could potentially reduce patient risk by avoiding unnecessary revision operations for replacement joints.”

Joint replacement is a surgical treatment option for people with severe joint damage, including the knees or hips. During a joint replacement surgery, the surgeon removes damaged cartilage and bone from the surface of the joint and replaces it with a prosthetic joint implant. Potential complications of joint replacement include scarring, inflammation, blood clots and infections. If an infection occurs, it can lead to pain, redness, swelling and decreased joint function and potentially require antibiotics and revision surgery to treat the infection and install a new prosthetic implant. Physicians typically evaluate for potential infections using X-ray images or laboratory analysis of joint fluid, which can take days for results…